An observational study in Breast Cancer (Locally Advanced or Metastatic), sponsored by Jie Yuan，MD. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Jie Yuan，MD · Observational
This prospective, single-center, open-label, real-world observational study plans to enroll 10-15 patients with advanced (Stage IV) breast cancer who have failed multiple prior therapies [aged 18-75, Eastern Cooperative Oncology Group Performance Status Clinical Classification（ECOG） 0-2, with measurable and injectable lesions]. It aims to preliminarily evaluate the antitumor activity, safety, and immune-microenvironment modulation of intratumoral H101（Recombinant Human Adenovirus Type 5 Injection） oncolytic virus combined with immune checkpoint inhibitors (ICIs) in real-world practice. The regimen is determined by physicians based on clinical status and multidisciplinary input, but follows a standardized framework: 2- to 3-week cycles; H101 injected on day 1 (dose stratified by lesion size), with ICI infusion started 7±2 days later, for 4 planned cycles. Paired tumor biopsies (when feasible) and peripheral blood are collected at baseline and after 4 cycles for single-cell RNA sequencing and immune profiling, focusing on changes in T lymphocyte (T), Natural Killer cell (NK), dendritic, and macrophage subsets and correlating with clinical outcomes. Primary endpoints include adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0（CTCAE v5.0）), objective response and local control rates (Response Evaluation Criteria in Solid Tumors Version 1.1（RECIST 1.1）), 4-cycle completion, and toxicity-related discontinuation. Secondary endpoints include disease control rate, progression-free survival (Kaplan-Meier), and dynamic immune changes. First radiological assessment occurs at 6-8 weeks post-treatment, then every 3 months until progression, loss to follow-up, or 1 year. If re-biopsy is unsafe, only peripheral blood may be collected without protocol violation. Comprehensive follow-up, data confidentiality, and missing-data handling are in place to ensure scientific validity and participant protection.
This study is a prospective, single-center, open-label, real-world observational clinical study that plans to enroll 10 to 15 patients with advanced (Stage IV) breast cancer who have failed multiple lines of prior therapy (aged 18-75 years, with ECOG performance status 0-2, and with measurable and injectable tumor lesions). It aims to preliminarily explore the antitumor activity, safety, and impact on the tumor immune microenvironment of intratumoral H101 oncolytic virus injection combined with immune checkpoint inhibitors (ICIs) in a real-world clinical setting. The study does not interfere with routine clinical decisions; the specific combination regimen (H101 intratumoral injection plus an anti-PD-1 or anti-CTLA-4 antibody) is determined by the attending physician based on the patient's condition, prior treatments, and multidisciplinary team recommendations. However, to ensure consistent observation, a standardized treatment framework is established: each cycle lasts 2-3 weeks; on day 1 of each cycle, H101 is injected intratumorally (dose stratified by lesion size according to the package insert, e.g., 5×10¹¹ VP per session with divided injections), and intravenous ICI infusion is started 7±2 days after the first injection, with a planned total of 4 cycles. To analyze biological changes before and after treatment, the study includes a systematic sampling plan: at baseline and after completion of 4 cycles, we attempt to re-biopsy the same accessible lesion whenever possible and also collect peripheral blood. These paired samples will be used for single-cell RNA sequencing and immune microenvironment analysis, focusing on changes in the composition, functional status, and differentially expressed genes of key immune cell subsets (T cells, NK cells, dendritic cells, macrophages), and correlating these changes with clinical efficacy indicators. For efficacy and safety evaluation, the primary endpoints include the incidence and severity of treatment-related adverse events (assessed by CTCAE v5.0), objective response rate and local lesion control rate (by RECIST 1.1), as well as feasibility and tolerability measured by the 4-cycle completion rate and the rate of treatment discontinuation due to toxicity. Secondary endpoints include disease control rate, progression-free survival (estimated using the Kaplan-Meier method for median survival time), and the paired dynamic changes in the above immune microenvironment markers from baseline to post-treatment. For follow-up and data collection, the first radiographic efficacy evaluation is performed 6-8 weeks after treatment completion, and then every 3 months thereafter until disease progression, loss to follow-up, or 1 year. In consideration of real-world operational practicality, if the injected lesion markedly shrinks, becomes necrotic, or cannot be safely re-biopsied after treatment, only peripheral blood samples may be collected without being considered a protocol violation. Comprehensive follow-up management, data confidentiality, and missing data handling measures are also in place to maximize the scientific rigor of the study and safeguard the rights and safety of participants.
This study will enroll 15 patients with advanced metastatic breast cancer presenting with multiple metastases, who have failed multiple prior lines of systemic therapy, and are aged 18 to 75 years. Subjects will be primarily recruited from the patient population at Foshan Fosun Chancheng Hospital. All eligible subjects must meet all inclusion criteria and none of the exclusion criteria.
Exclusion Criteria:
H101 (Recombinant Human Adenovirus Type 5 Injection)+Anti-Programmed Cell Death Protein 1 Antibody（Anti-PD-1 antibody） ± Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Antibody（anti-CTLA-4 antibody） H101 (Recombinant Human Adenovirus Type 5 Injection) Route of administration: Intratumoral injection Dose: Stratified dosing according to lesion size, using the dose specified in the package insert and the dose based on prior clinical experience (multipoint injection) Frequency: Once per cycle Treatment course: 2-3 weeks per cycle, for a total of 4 cycles Anti-PD-1 antibody ± anti-CTLA-4 antibody Initiation time: 7 ± 2 days after the first H101 injection Administration schedule: Once per cycle
Incidence of Adverse Events
Metric/method of measurement : Common Terminology Criteria for Adverse Events version 5.0
Time frame: From first dose of study treatment through 30 days after the last dose (up to approximately 8-12 weeks)
Objective Response Rate
Response Evaluation Criteria in Solid Tumors version 1.1
Time frame: 6-8 weeks after the end of treatment (after completion of 4 treatment cycles)
Local Control Rate
According to clinical and radiological assessment
Time frame: Baseline and every 3 months up to 1 year after the end of treatment
Treatment Feasibility
Measured by completion rate and adherence rate
Time frame: During the treatment period (up to 4 cycles, each cycle 2-3 weeks)
Tolerability of the study drug in participants
Tolerability will be assessed by the incidence, severity, and relatedness of TEAEs, and the proportion of participants who discontinue treatment due to TEAEs.
Time frame: From first dose of study treatment through 30 days after the last dose (up to approximately 8-12 weeks)
Disease Control Rate
Response Evaluation Criteria in Solid Tumors, version 1.1(RECIST 1.1 )
Time frame: Baseline and up to approximately 6 months (including 6-8 weeks after the end of treatment)
Progression-Free Survival
According to clinical and radiological assessment
Time frame: From first dose of study treatment until disease progression per RECIST v1.1 or death from any cause, whichever occurs first (up to approximately 2 years)
Plan to share: No — No, Individual Participant Data (IPD) will not be shared.
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